BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IBD-CHEK

    K Number: K011396 · Decision Jun 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    36
    Review Days
    42

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    Basic Information

    Device Name
    IBD-CHEK
    K Number
    K011396
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5570
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techlab, Inc.
    Date Received
    May 7, 2001
    Decision Date
    June 18, 2001
    Product Code
    DEG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DEG Lactoferrin, Antigen, Antiserum, Control

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